MANUFACTURING PROCESS TECHNICIAN NS

Job Description

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

Under limited supervision, performs manufacturing processes according to Standard Operating Procedures.

Perform initial review of manufacturing procedures and batch records

Train Manufacturing Operators and Associate Manufacturing staff on process theory

Draft and revise complex documents such as MPs, SOPs, technical reports, validation documents, and investigation reports

Audit critical records

Propose corrective actions for Quality incidents

Assist with and plan implementation of routine process improvements

Collaborate with other departments to execute planned improvements

Identify and propose solutions to complex problems

Perform data analysis (e.g., SPC, CPV) on critical process parameters

Serve as a lead for equipment and process operations

Support the generation and review of manufacturing procedures and related documentation

Troubleshoot processes and assess performance through monitoring

Support training activities

Participate in NC CAPA processes by conducting process assessments, joining cross-functional investigations, defining/implementing CAPAs, and reporting on incident trends

Assist in generating, reviewing, and executing process validation protocols

Support new product introductions and product life cycle activities

Initiate and implement Level 1 and Level 2 Change Control records

Qualifications:

Bachelors degree preferred

One year of experience in a manufacturing or facility environment, though those with less experience but a strong willingness to learn will also be considered.

Technical mindset, capable of understanding how equipment works and absorbing process knowledge, even if they haven’t worked in a scientific or pharmaceutical setting.

Experience with mechanical systems, such as working with cars, is seen as a plus.

A positive, team-oriented attitude and the ability to take instruction are essential.

GMP knowledge is preferred

11:30 AM to 8:00 PM.

Future/pre-ship shift: 3:00 PM to 11:30 PM.

Flexibility needed: Occasionally, workers may need to come in earlier (e.g., 6:30 AM to 3:00 PM), especially when coordination is required across team members.

Candidates must be open to occasional schedule adjustments.

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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